Philips Ultrasound, LLC recalls Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

On August 7, 2026, Philips issued a Urgent Medical Device Correction Notification to affected consignees. Philips requested consignees take the following actions: 1. Due to possibility of a weak PW Doppler Signal on EPIQ Elite running 14.0 SW, customers are advised not to use C5-1 Abd Vasc Tissue Specific Preset (TSP). Please use a different TSP (e.g., Abd Gen, Abd Renal) within C5-1. Please note that this issue (i.e., Weak PW Doppler signal) is restricted to the Abd Vasc TSP with C5-1 on EPIQ Elite running SW 14.0 only. 2. Otherwise, you may continue to use your device in accordance with the IFU. 3.Circulate this notice to all users of the device so that they are aware of the product issue and associated hazard / harm. 4. Post this notice near the affected unit(s) for ease of reference 5. Please return the completed response form at the end of this notice, indicating that information on this issue has been read and understood. Philips asks that you return the completed response form no later than 30 days from receipt of this letter.

• FDA enforcement recordOfficial FDA database entry for Z-3249-2026
• FDA 510(k) clearance · K260123The device's official FDA premarket clearance record
• FDA 510(k) clearance · K260680The device's official FDA premarket clearance record
• FDA device classification · IYNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1550The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips Ultrasound, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.